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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

HYDRASHIFT 2/4 isatuximab (40… — IVDR Class A IVDR by sebia

MD Atlas
sebia

EUDAMED last updated this device on Apr 2, 2026

HYDRASHIFT 2/4 isatuximab (40 TESTS)

3607364642BUEC

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: sebia
UDI-DI code: 03607360046425
Reference / catalog number: 4642

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Manufacturer information

Organization name: sebia
SRN: FR-MF-000003520
Manufacturer status: Active

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW009
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW032
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

Placed on the market in France; per-country availability dates not published.

Device identification

Trade name: HYDRASHIFT 2/4 isatuximab (40 TESTS)
UDI-DI code: 03607360046425
Basic UDI-DI: 3607364642BUEC
Reference / catalog number: 4642
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: No additional product description
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01029001ANTISERA (MONOVALENT AND POLYVALENT)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Expiration date
Manufacturing date
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Software identification